Krill Oil Study Compared to Fish Oil - Full Text View

Sponsor:	University of Manitoba
Collaborator:	Enzymotec
Information provided by (Responsible Party):	Dr. Peter Jones, University of Manitoba
ClinicalTrials.gov Identifier:	NCT01323036

Purpose

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.

Condition	Intervention
Healthy Volunteers	Dietary Supplement: Krill oil Dietary Supplement: Fish Oil

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

Bioavailability [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2011
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Krill Oil N/A	Dietary Supplement: Krill oil Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
Experimental: Fish Oil N/A	Dietary Supplement: Fish Oil Fish oil: Total omega-3 fatty acids: 560-660 mg

Detailed Description:

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.

Exclusion Criteria:

smokers
rheumatoid arthritis
chronic illness
cardiovascular problems
dyslipidemia
liver and kidney disease
diabetes
endocrine or metabolic disease
inflammatory bowel disease
pancreatitis
gallbladder or biliary disease
neurological/psychological disease
bleeding disorders
experienced platelet abnormalities
gastrointestinal disorders that could interfere with fat absorption
hypertension
history of cancer
an intention to lose weight
use of anticoagulant
serum triglycerides (TG) >200 mg/dL, and/or total cholesterol (TC) >240 mg/dL, and/or LDL-cholesterol (LDL-C) >160 mg/dL
hypertension or lipid lowering medications
consumption of more than one alcoholic drinks/day
Consumption of more than one fish or seafood serving
one month prior to the start of the study
omega-6 fatty acids in the past 6 months
planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
planned to to become pregnant during the study period
BMI>28
allergies to fish seafood or corn

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323036

Locations

Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2

Sponsors and Collaborators

University of Manitoba

Enzymotec

More Information

No publications provided

Responsible Party:	Dr. Peter Jones, Director of RCFFN, University of Manitoba
ClinicalTrials.gov Identifier:	NCT01323036 History of Changes
Other Study ID Numbers:	B2011:014
Study First Received:	March 23, 2011
Last Updated:	October 19, 2011
Health Authority:	Israel: Helsinki Committee

ClinicalTrials.gov processed this record on May 23, 2012